Apparatus and method for an ultrasonic probe used with a pharmacological agent

ABSTRACT

The present invention provides an apparatus and a method of using an ultrasonic probe with a pharmacological agent to enhance an occlusion treating effect of the ultrasonic probe to effectively remove an occlusion. The pharmacological agent is released through a catheter to treat the occlusion and enhance an effect of a transverse ultrasonic vibration of the ultrasonic probe to effectively remove the occlusion. The pharmacological agent continues to travel downstream of the site of the occlusion and work in conjunction with the ultrasonic probe to reduce the occlusion to a size that can easily be removed from the body naturally in order to prevent reformation of the occlusion and other health risks.

RELATED APPLICATIONS

[0001] This application is a continuation of 10/396,914, filed Mar. 25,2003 which is a continuation-in-part of application Ser. No. 10/373,134,filed Feb. 24, 2003, which is a continuation of application Ser. No.09/784,619, filed Feb. 15, 2001, now U.S. Pat. No. 6,524,251, which is acontinuation-in-part of application Ser. No. 09/618,352, filed on Jul.19, 2000, now U.S. Pat. No. 6,551,337, which claims the benefit ofProvisional Application Serial No. 60/178,901, filed Jan. 28, 2000, andclaims the benefit of Provisional Application Serial No. 60/157,824,filed Oct. 5, 1999, the entirety of all these applications are herebyincorporated herein by reference.

FIELD OF THE INVENTION

[0002] The present invention relates to an ultrasonic medical device,and more particularly to an apparatus and method of using an ultrasonicprobe with a pharmacological agent to treat an occlusion and effectivelyremove the occlusion and prevent subsequent occlusion formation andother health risks.

BACKGROUND OF THE INVENTION

[0003] Vascular occlusive disease affects millions of individualsworldwide and is characterized by a dangerous blockage of vasculatures.Vascular occlusive disease includes thrombosed hemodialysis grafts,peripheral artery disease, deep vein thrombosis, coronary arterydisease, heart attack and stroke. Vasculatures include veins, arteries,blood vessels, intestines, ducts and other body lumens that materialsmay flow through. Heart attacks are an especially common vascularocclusive disease, with an approximate annual rate of 800,000 people inthe United States having acute heart attacks with approximately 213,000of those people dying. Strokes are also common, with approximately 80%of all strokes being ischemic strokes caused when a vascular occlusionformed in one part of the body travels to a smaller blood vessel in thebrain and inhibits blood flow to the brain. Vascular occlusions (clots,intravascular blood clots or thrombus, occlusional deposits, such ascalcium deposits, fatty deposits, atherosclerotic plaque, cholesterolbuildup, fibrous material buildup, arterial stenoses) result in therestriction or blockage of blood flow in the vasculatures in which theyoccur. Occlusions result in oxygen deprivation (“ischemia”) of tissuessupplied by these blood vessels. Prolonged ischemia results in permanentdamage of tissues which can lead to myocardial infarction, stroke ordeath. Occlusions frequently occur in coronary arteries, peripheralarteries and other blood vessels.

[0004] The disruption of an occlusion can be affected by mechanicalmethods, ultrasonic methods, pharmacological agents or combinations ofall three. Many procedures involve inserting an insertion lumen into avasculature of a body. Insertion lumens include, but are not limited to,probes, catheters, wires, tubes and similar devices.

[0005] Mechanical methods of treating thrombolysis include balloonangioplasty, which can result in ruptures in a blood vessel, and isgenerally limited to larger blood vessels. In addition, scarring ofvessels is common, which may lead to the formation of a secondaryocclusion (a process known as restenosis). Another common problem issecondary vasoconstriction (classic recoil), a process by which spasmsor an abrupt closure of the blood vessel occurs. These problems arecommon in treatments employing interventional devices. In traditionalangioplasty, for instance, a balloon catheter is inserted into theocclusion, and through the application of hydraulic forces in the rangeof about ten to about fourteen atmospheres of pressure, the balloon isinflated. The non-compressible balloon applies this significant force tocompress and flatten the occlusion, thereby opening the vessel for bloodflow. However, these extreme forces result in the application of extremestresses to the vessel, potentially rupturing the vessel, or weakeningit and thereby increasing the chance of post-operative aneurysm, orcreating vasoconstrictive or restenotic conditions. In addition, theparticulate matter forming the occlusion is not removed, rather it isjust compressed. Other mechanical devices that drill through and attemptto remove an occlusion have also been used, and create the same dangerof physical damage to blood vessels.

[0006] Ultrasonic probes using ultrasonic energy to fragment body tissuehave been used in many surgical procedures (see, e.g., U.S. Pat. No.5,112,300; U.S. Pat. No. 5,180,363; U.S. Pat. No. 4,989,583; U.S. Pat.No. 4,931,047; U.S. Pat. No. 4,922,902; and U.S. Pat. No. 3,805,787).Ultrasonic devices used for vascular treatments typically comprise anextracorporeal transducer coupled to a solid metal wire which is thenthreaded through the blood vessel and placed in contact with anocclusion (see, e.g., U.S. Pat. No. 5,269,297). In some cases, thetransducer, comprising a bendable plate, is delivered to the site of theclot (see, e.g., U.S. Pat. No. 5,931,805).

[0007] Some ultrasonic devices include a mechanism for irrigating anarea where the ultrasonic treatment is being performed (e.g., a bodycavity or lumen) in order to wash biological material from the area oftreatment. Mechanisms used for irrigation or aspiration known in the artare generally structured such that they increase the overallcross-sectional profile of the elongated probe, by including inner andouter concentric lumens within an ultrasonic probe to provide irrigationand aspiration channels. In addition to making the probe more invasive,prior art probes also maintain a strict orientation of the aspirationand the irrigation mechanism, such that the inner and outer lumens forirrigation and aspiration remain in a fixed position relative to oneanother, which is generally closely adjacent to the area of treatment.Thus, the irrigation lumen does not extend beyond the suction lumen(i.e., there is no movement of the lumens relative to one another) andany aspiration is limited to picking up fluid and/or tissue remnantswithin the defined area between the two lumens.

[0008] As discussed above, medical devices utilizing ultrasonic energyto destroy material comprising an occlusion in the human body are knownin the art. A major drawback of prior art ultrasonic devices comprisinga probe for occlusion removal is that the devices are relatively slow incomparison to procedures that involve surgical excision. This is mainlyattributed to the fact that such ultrasonic devices rely on impartingultrasonic energy to contacting occlusions by undergoing a longitudinalvibration of the probe tip, wherein the probe tip is mechanicallyvibrated at an ultrasonic frequency in a direction parallel to the probelongitudinal axis. Thus, the treatment area is localized at the probetip, which substantially limits its ability to ablate large occlusionareas in a short time. An ultrasonic medical device with a multiplematerial coaxial construction for conducting axial vibrations is knownin the art (see, e.g., U.S. Pat. No. 6,277,084). In addition to priorart ultrasonic devices being slow, previous ultrasonic methods oftreating plaque still include many undesirable complications and dangersto the patient.

[0009] The use of a pharmacological agent alone to treat a vascularocclusion is common, but suffers from a variety of limitations thatcompromise the effectiveness of the removal of the vascular occlusion.It is difficult to disperse the pharmacological agent symmetrically tothe vascular occlusion, thereby leaving portions of the vascularocclusion untreated. Often, portions of the vascular occlusion arecarried downstream of the site of the vascular occlusion and lead tofurther problems including embolism. In addition, delivery of thepharmacological agent is inefficient and infusion times are long as theagent naturally dissolves into areas of the vascular occlusion. Adversecomplications such as hemorrhages and bleeding are also common, therebycreating additional health risks beyond those presented by the vascularocclusion. Finally, large quantities of the pharmacological agent areneeded to treat the thrombus, thereby driving up the cost of thetreatment.

[0010] Prior art attempts to safely and effectively ablate an occlusionin a vasculature of a body have been less than successful. U.S. Pat. No.6,508,782 to Evans et al. discloses a catheter for dissolving blockagesin tissues. The Evans et al. device uses a catheter with an inflatablemember either alone or in conjunction with a medicament for dissolvingthe blockages. The Evans et al. device discloses a catheter with aninflatable member near the distal tip of the catheter to prevent theblockage from passing downstream of the blockage and a perfusion channelfor removal of the broken up blockage. The Evans et al. device iscomplicated, unreliable and necessitates a time consuming procedure thatrequires the exchange of various lumens to deliver the medicament and tovibrate the Evans et al. device. Since vibratory motion for the Evans etal. device is longitudinal and at a distal tip, the Evans et al. devicedoes not focus on all parts of the blockage and does not effectively andefficiently remove the blockage. Therefore, there remains a need in theart for effectively ablating an occlusion that combines the ultrasonicenergy of an ultrasonic probe with the dissolving effects of apharmacological agent that is simple, quick, reliable, efficient,effective, does not harm healthy tissue and continues to break upparticulate of the occlusion downstream to prevent occlusion formationdownstream.

[0011] U.S. Pat. No. 5,925,016 to Chornenky et al. discloses a systemand a method for treating thrombosis by moving drugs through thethrombus by pressure. The Chornenky et al. device isolates the thrombusby using a catheter with an occlusion balloon proximal to the thrombus,a guide wire with an occlusion placed distal to the thrombus, and aninfusion catheter that delivers drugs distal to the thrombus throughpressure. Since the Chornenky et al. device relies on the drug and thenon-symmetric pressurized delivery of the drug to remove the thrombus,the thrombus is not effectively removed and may result in complicationsdownstream of the thrombus. The Chornenky et al. device uses a timeconsuming procedure that imparts high stresses to the vessel walls thatcan damage the vessel. Therefore, there remains a need in the art foreffectively ablating an occlusion that combines the ultrasonic energy ofan ultrasonic probe with the dissolving effects of a pharmacologicalagent that is simple, quick, reliable, efficient, effective, does notharm healthy tissue and continues to break up particulate of theocclusion downstream to prevent occlusion formation downstream.

[0012] U.S. Pat. No. 6,280,413 to Clark et al. discloses a thrombolyticfiltration and drug delivery catheter comprising a shaft andlongitudinal ribs that are compressed when moved to the treatment siteand expand to a diameter greater than the shaft of the catheter. In theClark et al. device, drugs are delivered through a lumen in the catheterand are delivered through ports in the ribs. Since the Clark et al.device relies on the non-symmetric dispersion of the drug, the Clark etal. device does not effectively remove an occlusion and the occlusioncan reform downstream. The Clark et al. device is complicated and relieson a separate lumen to remove the particles of the thrombus. Inaddition, the longitudinal ribs of the Clark et. al. device can imparthigh stresses to the vasculature and harm healthy tissue. Therefore,there remains a need in the art for effectively ablating an occlusionthat combines the ultrasonic energy of an ultrasonic probe with thedissolving effects of a pharmacological agent that is simple, quick,reliable, efficient, effective, does not harm healthy tissue andcontinues to break up particulate of the occlusion downstream to preventocclusion formation downstream.

[0013] The prior art attempts of removing an occlusion from avasculature in a body are complicated, expensive, unsafe, ineffective,time consuming, inefficient and compromise the health of a patient bypotentially allowing the occlusion to reform downstream. Therefore,there remains a need in the art for effectively ablating an occlusionthat combines the ultrasonic energy of an ultrasonic probe with thedissolving effects of a pharmacological agent that is simple, quick,reliable, efficient, effective, does not harm healthy tissue andcontinues to break up particulate of the occlusion downstream to preventocclusion formation downstream.

SUMMARY OF THE INVENTION

[0014] The present invention relates to an ultrasonic medical device,and more particularly to an apparatus and method of using an ultrasonicprobe with a pharmacological agent to treat an occlusion and effectivelyremove the occlusion and prevent subsequent occlusion formation andother health risks.

[0015] The present invention is an ultrasonic medical device comprisingan ultrasonic probe and a catheter surrounding a length of alongitudinal axis of the ultrasonic probe used with a pharmacologicalagent. In a preferred embodiment of the present invention, the catheterdelivers the pharmacological agent to treat the occlusion. In apreferred embodiment of the present invention, the pharmacological agentis tissue plasminogen activator (tPA). The pharmacological agentenhances an occlusion treatment effect of the ultrasonic probe.

[0016] The present invention is an ultrasonic medical device comprisingan elongated, flexible probe and a catheter surrounding a length of alongitudinal axis of the elongated, flexible probe. A pharmacologicalagent moves through the catheter and enhances an effect of a transverseultrasonic vibration of the elongated, flexible probe to treat theocclusion. The transverse ultrasonic vibration of the elongated,flexible probe produces a plurality of transverse nodes and transverseanti-nodes along a portion of the longitudinal axis of the elongated,flexible probe.

[0017] The present invention provides a method of treating an occlusionthrough the combined effects of an ultrasonic probe and apharmacological agent. The ultrasonic probe is inserted into avasculature, a catheter is delivered over a length of a longitudinalaxis of the ultrasonic probe and a pharmacological agent is releasedthrough the catheter. A section of the longitudinal axis of theultrasonic probe is exposed to the occlusion and an ultrasonic energysource is activated. The pharmacological agent continues to movedownstream of a site of the occlusion to work in conjunction with theultrasonic probe to reduce the occlusion to a size that can easily beremoved from the body in conventional ways or simply dissolve into theblood stream.

[0018] The present invention provides a method of removing an occlusionby moving an elongated, flexible probe through a vasculature to a siteof an occlusion, releasing a pharmacological agent in the vasculatureand activating an ultrasonic energy source to vibrate a longitudinalaxis of the ultrasonic probe. The pharmacological agent enhances anocclusion destroying effect of the elongated, flexible probe.

[0019] The present invention is an ultrasonic medical device and apharmacological agent used together to treat an occlusion andefficiently remove the occlusion to prevent subsequent reformation ofthe occlusion and other health risks. The present invention provides anapparatus and a method for more completely removing an occlusion that issafe, simple, efficient, effective, user-friendly, reliable and costeffective.

BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The present invention will be further explained with reference tothe attached drawings, wherein like structures are referred to by likenumerals throughout the several views. The drawings shown are notnecessarily to scale, with emphasis instead generally being placed uponillustrating the principles of the present invention.

[0021]FIG. 1 shows a longitudinal cross section of a vasculature showingan ultrasonic medical device of the present invention capable ofoperating in a transverse mode inserted into the vasculature to treat anocclusion.

[0022]FIG. 2 shows a side plan view of an ultrasonic medical device ofthe present invention capable of operating in a transverse mode.

[0023]FIG. 3 shows a side plan view of an ultrasonic medical device ofthe present invention capable of operating in a transverse mode with acatheter surrounding a length of a longitudinal axis of an ultrasonicprobe.

[0024]FIG. 4 shows a side plan view of an alternative embodiment of anultrasonic medical device of the present invention showing a pluralityof transverse nodes and a plurality of transverse anti-nodes along aportion of a longitudinal axis of the ultrasonic probe.

[0025]FIG. 5 shows a fragmentary side plan view of a distal end of anultrasonic probe within a catheter.

[0026]FIG. 6 shows a fragmentary side plan view of a distal end of anultrasonic probe within a catheter wherein a section of a longitudinalaxis of the ultrasonic probe extends beyond a distal end of thecatheter.

[0027] While the above-identified drawings set forth preferredembodiments of the present invention, other embodiments of the presentinvention are also contemplated, as noted in the discussion. Thisdisclosure presents illustrative embodiments of the present invention byway of representation and not limitation. Numerous other modificationsand embodiments can be devised by those skilled in the art which fallwithin the scope and spirit of the principles of the present invention.

DETAILED DESCRIPTION

[0028] The present invention provides an apparatus and a method of usingan ultrasonic probe with a pharmacological agent to enhance an occlusiontreating effect of the ultrasonic probe to effectively remove anocclusion. The pharmacological agent treats the occlusion at the site ofthe occlusion and continues to travel downstream to further break up aparticulate from the occlusion into an aggregate with a size smallerthan the particulate. In a preferred embodiment of the presentinvention, the pharmacological agent is tissue plasminogen activator(tPA).

[0029] The following terms and definitions are used herein:

[0030] “Ablate” as used herein refers to removing, clearing, destroyingor taking away a biological material. “Ablation” as used herein refersto a removal, clearance, destruction, or taking away of the biologicalmaterial.

[0031] “Node” as used herein refers to a region of a minimum energyemitted by an ultrasonic probe at or proximal to a specific locationalong a longitudinal axis of the ultrasonic probe.

[0032] “Anti-node” as used herein refers to a region of a maximum energyemitted by an ultrasonic probe at or proximal to a specific locationalong a longitudinal axis of the ultrasonic probe.

[0033] “Probe” as used herein refers to a device capable of propagatingan energy emitted by the ultrasonic energy source along a longitudinalaxis of the ultrasonic probe, resolving the energy into an effectivecavitational energy at a specific resonance (defined by a plurality ofnodes and a plurality of anti-nodes along an “active area” of the probe)and is capable of an acoustic impedance transformation of ultrasoundenergy to a mechanical energy.

[0034] “Transverse” as used herein refers to a vibration of a probe notparallel a longitudinal axis of the probe. A “transverse wave” as usedherein is a wave propagated along the probe in which a direction of adisturbance at a plurality of points of a medium is not parallel to awave vector.

[0035] “Biological material” as used herein refers to a collection of amatter including, but not limited to, a group of similar cells,intravascular blood clots or thrombus, fibrin, calcified plaque, calciumdeposits, occlusional deposits, atherosclerotic plaque, fatty deposits,adipose tissues, atherosclerotic cholesterol buildup, fibrous materialbuildup, arterial stenoses, minerals, high water content tissues,platelets, cellular debris, wastes and other occlusive materials.

[0036] “Occlusion” as used herein refers to a blockage, a clot, abuildup or a deposit of a matter that results in an obstruction,restriction, obstruction, constriction, blockage or closure at a site ofthe occlusion.

[0037] “Particulate” as used herein refers to a smaller portionseparated from a larger occlusion and distinct from the occlusion.

[0038] “Aggregate” as used herein refers to a smaller portion separatedfrom a particulate that is distinct from the particulate.

[0039]FIG. 1 illustrates a section of an ultrasonic medical device 11 ofthe present invention proximal to an occlusion 16 inside a vasculature44. The ultrasonic medical device 11 includes an ultrasonic probe 15with a probe tip 9 at a distal end 24 of the ultrasonic probe 15. Acatheter 36 (shown in a retracted position) surrounds a length of alongitudinal axis of the ultrasonic probe 15 and comprises a pluralityof fenestrations 13 spaced circumferentially along a length of thecatheter 36. In a preferred embodiment of the present invention, theplurality of fenestrations 13 are located at a distal end 34 of thecatheter 36. A pharmacological agent moves through an open area 19between the ultrasonic probe 15 and the catheter 36.

[0040] In a preferred embodiment of the present invention, thepharmacological agent moves through the plurality of fenestrations 13 atthe distal end 34 of the catheter 36. The catheter 36 with the pluralityof fenestrations 13 allows for the pharmacological agent to uniformlyengage the occlusion 16 as the pharmacological agent moves in a radialdirection through the plurality of fenestrations 13. In anotherembodiment of the present invention, the pharmacological agent movesthrough an opening 35 at a distal end 34 of the catheter 36. In anotherembodiment of the present invention, the pharmacological agent movesthrough one fenestration 13 at a position along the longitudinal axis ofthe catheter 36. Those skilled in the art will recognize apharmacological agent can be moved through a catheter to engage anocclusion in many ways known in the art and be within the spirit andscope of the present invention.

[0041]FIG. 2 shows the ultrasonic medical device 11 of the presentinvention. The ultrasonic medical device 11 includes the ultrasonicprobe 15 which is coupled to an ultrasonic energy source or generator 99(shown in phantom in FIGS. 2-4) for the production of an ultrasonicenergy. A handle 88, comprising a proximal end 87 and a distal end 86,surrounds a transducer within the handle 88. The transducer having afirst end engaging the ultrasonic energy source 99 and a second endengaging a proximal end 31 of the ultrasonic probe 15 transmits anultrasonic energy to the ultrasonic probe 15. A connector 93 engages theultrasonic energy source 99 to the transducer within the handle 88. Theultrasonic probe 15 includes the proximal end 31 and the distal end 24that ends in the probe tip 9. A diameter of the ultrasonic probe 15decreases from a first defined interval 26 to a second defined interval28 along the longitudinal axis of the ultrasonic probe 15 over an atleast one diameter transition 82. A quick attachment-detachment system33 that engages the proximal end 31 of the ultrasonic probe 15 to thetransducer within the handle 88 is illustrated generally in FIG. 2. Anultrasonic probe device with a rapid attachment and detachment means isdescribed in the Assignee's co-pending patent applications U.S. Ser. No.09/975,725, now U.S. Pat. No. 6,695,782; U.S. Ser. No. 10/268,487; U.S.Ser. No. 10/268,843, which further describe the quickattachment-detachment (QAD) system and the entirety of theseapplications are hereby incorporated herein by reference.

[0042]FIG. 3 shows the ultrasonic medical device 11 with a catheter 36surrounding a length of the longitudinal axis of the ultrasonic probe15. The catheter 36 comprises a proximal end 37, a distal end 34 and theplurality of fenestrations 13 along a longitudinal axis of the catheter36. In the embodiment of the present invention shown in FIG. 3, thecatheter 36 includes a port 84, a one or more placement wings 95 and aone or more valves 97. A connective tubing 79 engages the catheter 36 atthe port 84 and the connective tubing 79 can be opened or closed withone or more valves 97. The catheter 36 comprises the one or moreplacement wings 95 to assist in the placement of the catheter 36.

[0043] The catheter 36 is a thin, flexible, hollow tube that is smallenough to be threaded through a vein or an artery to deliver fluids intoor withdraw fluids from a body. The catheter 36 provides a pathway fordrugs, nutrients or blood products. Patients generally do not feel themovement of the catheter 36 through their body. Once in place, thecatheter 36 allows a number of tests or other treatment procedures to beperformed. Those skilled in the art will recognize that many cathetersknown in the art can be used with the present invention and still bewithin the spirit and scope of the present invention.

[0044] The catheter 36 of the ultrasonic medical device 11 surrounds alength of the longitudinal axis of the ultrasonic probe 15. In anembodiment of the present invention shown in FIG. 3, the catheter 36spans a length of the ultrasonic probe 15 along the first definedinterval 26 and the second defined interval 28. In another embodiment ofthe present invention, the catheter 36 spans a length of the ultrasonicprobe 15 along the second defined interval 28. In another embodiment ofthe present invention, the catheter 36 spans a length of the ultrasonicprobe 15 along the first defined interval 26. Those skilled in the artwill recognize the catheter 36 can span any length of the ultrasonicprobe 15 and be within the spirit and scope of the present invention.

[0045] The probe tip 9 can be any shape including, but not limited to,bent, a ball or larger shapes. In one embodiment of the presentinvention, the ultrasonic energy source 99 is a physical part of theultrasonic medical device 11. In another embodiment of the presentinvention, the ultrasonic energy source 99 is not a physical part of theultrasonic medical device 11.

[0046] The handle 88 surrounds the transducer located between theproximal end 31 of the ultrasonic probe 15 and the connector 93. In apreferred embodiment of the present invention, the transducer includes,but is not limited to a horn, an electrode, an insulator, a backnut, awasher, a piezo microphone, and a piezo drive. The transducer convertselectrical energy provided by the ultrasonic energy source 99 tomechanical energy. The transducer transmits ultrasonic energy receivedfrom the ultrasonic energy source 99 to the ultrasonic probe 15. Energyfrom the ultrasonic energy source 99 is transmitted along thelongitudinal axis of the ultrasonic probe 15, causing the ultrasonicprobe 15 to vibrate in a transverse mode. The transducer is capable ofengaging the ultrasonic probe 15 at the proximal end 31 with sufficientrestraint to form an acoustical mass that can propagate the ultrasonicenergy provided by the ultrasonic energy source 99.

[0047] The ultrasonic probe 15 has a stiffness that gives the ultrasonicprobe 15 a flexibility so it can be articulated in the vasculature 44 ofthe body. In a preferred embodiment of the present invention shown inFIG. 1, the ultrasonic probe 15 is a wire. In a preferred embodiment ofthe present invention shown in FIG. 1, the diameter of the ultrasonicprobe 15 decreases from the first defined interval 26 to the seconddefined interval 28. In another embodiment of the present invention, thediameter of the ultrasonic probe 15 decreases at greater than twodefined intervals. In a preferred embodiment of the present invention,the diameter transitions 82 of the ultrasonic probe 15 are tapered togradually change the diameter from the proximal end 31 to the distal end24 along the longitudinal axis of the ultrasonic probe 15. In anotherembodiment of the present invention, the diameter transitions 82 of theultrasonic probe 15 are stepwise to change the diameter from theproximal end 31 to the distal end 24 along the longitudinal axis of theultrasonic probe 15. Those skilled in the art will recognize that therecan be any number of defined intervals and diameter transitions and thatthe diameter transitions can be of any shape known in the art and bewithin the spirit and scope of the present invention.

[0048] In a preferred embodiment of the present invention shown in FIG.2, a cross section of the ultrasonic probe 15 is circular. In otherembodiments of the present invention, the shape of the cross section ofthe ultrasonic probe 15 includes, but is not limited to, square,trapezoidal, oval, triangular, circular with a flat spot and similarcross sections. Those skilled in the art will recognize that other crosssectional geometric configurations known in the art would be within thespirit and scope of the present invention.

[0049] The pharmacological agent is advanced through the connectivetubing 79, the one or more valves 97 are opened and the pharmacologicalagent moves through the catheter 36 and out the plurality offenestrations 13. In a preferred embodiment of the invention, thepharmacological agent moves through the plurality of fenestrations 13along the length of the catheter 36 and is approximately uniformlydistributed to the occlusion 16. In a preferred embodiment of thepresent invention, the occlusion 16 comprises a biological material. Ina preferred embodiment of the present invention, the occlusion 16 is avascular occlusion 16. The movement of the pharmacological agent allowsthe pharmacological agent to become localized at the occlusion 16 in anapproximately uniform distribution to the occlusion 16. Thepharmacological agent treats the occlusion 16 at the site of theocclusion 16 and enhances an occlusion treating effect of the ultrasonicprobe 15. After the pharmacological agent is distributed to theocclusion 16, the ultrasonic energy source 99 is activated and energy istransmitted along the longitudinal axis of the ultrasonic probe 15 andthe ultrasonic probe 15 vibrates in a transverse mode.

[0050] The transverse mode of vibration of the ultrasonic probe 15according to the present invention differs from an axial (orlongitudinal) mode of vibration disclosed in the prior art. Rather thanvibrating in an axial direction, the ultrasonic probe 15 of the presentinvention vibrates in a direction transverse (not parallel) to the axialdirection. As a consequence of the transverse vibration of theultrasonic probe 15, the occlusion destroying effects of the ultrasonicmedical device 11 are not limited to those regions of the ultrasonicprobe 15 that may come into contact with the occlusion 16. Rather, as asection of the longitudinal axis of the ultrasonic probe 15 ispositioned in proximity to an occlusion, a diseased area or lesion, theocclusion 16 is removed in all areas adjacent to a plurality ofenergetic transverse nodes and transverse anti-nodes that are producedalong a portion of the longitudinal axis of the ultrasonic probe 15,typically in a region having a radius of up to about 6 mm around theultrasonic probe 15.

[0051] Transversely vibrating ultrasonic probes for occlusion treatmentare described in the Assignee's co-pending patent applications U.S. Ser.No. 09/776,015, now U.S. Pat. No. 6,652,547; U.S. Ser. No. 09/618,352,now U.S. Pat. No. 6,551,337; and U.S. Ser. No. 09/917,471, now U.S. Pat.No. 6,695,781, which further describe the design parameters for such anultrasonic probe and its use in ultrasonic devices for a treatment, andthe entirety of these applications are hereby incorporated herein byreference.

[0052]FIG. 4 illustrates an alternative embodiment of the ultrasonicmedical device 11 wherein the ultrasonic probe 15 comprises anapproximately uniform diameter. The ultrasonic probe 15 comprises aplurality of transverse nodes 40 and transverse anti-nodes 42 atrepeating intervals along a portion of the longitudinal axis of theultrasonic probe 15.

[0053] A length and the cross section of the ultrasonic probe 15 aresized to support the transverse ultrasonic vibration with a plurality oftransverse nodes 40 and transverse anti-nodes 42 along the portion ofthe longitudinal axis of the ultrasonic probe 15. In a preferredembodiment of the present invention, more than one of the plurality oftransverse anti-nodes 42 are in communication with the occlusion 16. Thetransverse ultrasonic vibration produces the plurality of transversenodes 40 and transverse anti-nodes 42 along the portion of thelongitudinal axis of the ultrasonic probe 15. The transverse nodes 40are areas of minimum energy and minimum vibration. A plurality oftransverse anti-nodes 42, or areas of maximum energy and maximumvibration, also occur at repeating intervals along the portion of thelongitudinal axis of the ultrasonic probe 15. The number of transversenodes 40 and transverse anti-nodes 42, and the spacing of the transversenodes 40 and transverse anti-nodes 42 of the ultrasonic probe 15 dependon the frequency of the energy produced by the ultrasonic energy source99. The separation of the transverse nodes 40 and the transverseanti-nodes 42 is a function of the frequency, and can be affected bytuning the ultrasonic probe 15. In a properly tuned ultrasonic probe 15,the transverse anti-nodes 42 will be found at a position exactlyone-half of the distance between the transverse nodes 40 locatedadjacent to each side of the transverse anti-nodes 42.

[0054] As a consequence of the transverse vibration of the ultrasonicprobe 15, the occlusion destroying effects of the ultrasonic medicaldevice 11 are not limited to those regions of the probe 15 that may comeinto contact with the occlusion 16. Rather, as the ultrasonic probe 15is swept through an area of the occlusion 16, preferably in awindshield-wiper fashion, the occlusion 16 is removed in all areasadjacent to the plurality of transverse anti-nodes 42 being producedalong the portion of the longitudinal axis of the ultrasonic probe 15.The extent of a cavitational energy produced by the ultrasonic probe 15is such that the cavitational energy extends radially outward from thelongitudinal axis of the ultrasonic probe 15 at the transverseanti-nodes 42 along the longitudinal axis of the ultrasonic probe 15. Inthis way, actual treatment time using the transverse mode ultrasonicmedical device 11 according to the present invention is greatly reducedas compared to methods disclosed in the prior art that primarily utilizelongitudinal vibration (along the axis of the ultrasonic probe) fortreatment of the occlusion. Utilizing longitudinal vibration limitstreatment to the tip of the probe in prior art devices.

[0055] The use of the pharmacological agent in combination with thetransverse vibration of the ultrasonic probe 15 enhances the occlusiontreating effect of the present invention, causing the occlusion 16 to bebroken up into a particulate. Some of the occlusion 16 may be completelyremoved from the vasculature 44 at the site of the occlusion 16 whilesome may reside in the vasculature 44 as a particulate downstream of thesite of the occlusion 16. Sizes of the particulate vary from a smallsize that can be easily absorbed and discharged through the body inconventional ways to a size that may have a risk of a subsequentocclusion 16 formation downstream. The pharmacological agent treats theocclusion 16 and a portion of the occlusion 16 may be removed while theparticulate is created. The removal of the occlusion 16 and the breakingup of the occlusion 16 into the particulate is done through a generationof multiple cavitational transverse anti-nodes 42 along the portion ofthe longitudinal axis of the ultrasonic probe 15 not parallel to thelongitudinal axis of the ultrasonic probe 15. Since substantially largeraffected areas can be denuded of the occlusion 16 in a short time,actual treatment time using the transverse mode ultrasonic medicaldevice 11 according to the present invention is greatly reduced ascompared to methods using prior art probes that primarily utilizelongitudinal vibration (along the axis of the probe) for ablation. Adistinguishing feature of the present invention is the ability toutilize ultrasonic probes 15 of extremely small diameter compared toprior art probes, without loss of efficiency, because the occlusionfragmentation process is not dependent on the area of the probe tip 9.Highly flexible ultrasonic probes 15 can therefore be designed to mimicdevice shapes that enable facile insertion into occlusion spaces orextremely narrow interstices that contain the material comprising theocclusion 16. Another advantage provided by the present invention is theability to remove the occlusion 16 from large areas within cylindricalor tubular surfaces.

[0056] The pharmacological agent continues to travel downstream of thesite of the occlusion 16 and continues to treat the particulate. Thesizes of the particulate that are created by the fragmentation of theocclusion 16 may cause a formation of an occlusion 16 downstream fromthe treatment site. With the ultrasonic energy source 99 activated andthe pharmacological agent continuing to travel downstream of the site ofthe occlusion 16 to treat the particulate, the remaining particulate isbroken down further into an aggregate. The particulate and aggregate aresimilar in size to red blood cells. The size of the aggregate is suchthat the aggregate is easily discharged from the body throughconventional ways or simply dissolves into the blood stream. Aconventional way of discharging the aggregate from the body includestransferring the aggregate through the blood stream to the kidney wherethe aggregate is excreted as bodily waste. The combination effects ofthe transverse vibrations of the ultrasonic probe 15 with thepharmacological agent provides for ablation of the occlusion 16.

[0057] A significant advantage of the present invention is that theultrasonic medical device 11 physically destroys and removes thematerial comprising the occlusion 16 (especially adipose or other highwater content tissue) through the mechanism of non-thermal cavitation.In a preferred embodiment of the present invention, the occlusion 16comprises a biological material. In a preferred embodiment of thepresent invention, the occlusion 16 is a vascular occlusion 16.Cavitation is a process in which small voids are formed in a surroundingfluid through the rapid motion of the ultrasonic probe 15 and the voidsare subsequently forced to compress. The compression of the voidscreates a wave of acoustic energy which acts to dissolve the matrixbinding together the occlusion 16, while having no damaging effects onhealthy tissue. The ultrasonic energy source 99 provides a low powerelectric signal of approximately 2 watts to the transducer, which thentransforms the electric signal into acoustic energy. Longitudinal motioncreated within the transducer is converted into a standing transversewave along the portion of the longitudinal axis of the ultrasonic probe15, which generates acoustic energy in the surrounding medium throughcavitation. The acoustic energy dissolves the matrix of the occlusion16.

[0058] The ultrasonic energy produced by the ultrasonic probe 15 is inthe form of very intense, high frequency sound vibrations that result inphysical reactions in the water molecules within a body tissue orsurrounding fluids in proximity to the ultrasonic probe 15. Thesereactions ultimately result in a process called “cavitation,” which canbe thought of as a form of cold (i.e., non-thermal) boiling of the waterin the body tissue, such that microscopic voids are rapidly created anddestroyed in the water creating cavities in their wake. As surroundingwater molecules rush in to fill the cavity created by the collapsedvoids, they collide with each other with great force. Cavitation resultsin shock waves running outward from the collapsed voids which can wearaway or destroy material such as surrounding tissue in the vicinity ofthe ultrasonic probe 15.

[0059] The removal of the occlusion 16 by cavitation and the treatmentof the pharmacological agent also provides the ability to remove largevolumes of material comprising the occlusion 16 with the small diameterultrasonic probe 15, while not affecting healthy tissue. The use of thepharmacological agent and cavitation as the mechanism for destroying theocclusion 16 allows the present invention to destroy and remove thematerial comprising the occlusion 16 within a range of temperatures ofabout ±7° C. from normal body temperature. Therefore, complicationsattendant with the use of thermal destruction or necrosis, such asswelling or edema, as well as loss of elasticity are avoided.

[0060] The number of transverse nodes 40 and transverse anti-nodes 42occurring along the longitudinal axis of the ultrasonic probe 15 ismodulated by changing the frequency of energy supplied by the ultrasonicenergy source 99. The exact frequency, however, is not critical and forthe ultrasonic probe 15, the ultrasonic energy source 99 run at, forexample, about 20 kHz is generally sufficient to create an effectivenumber of occlusion destroying transverse anti-nodes 42 along thelongitudinal axis of the ultrasonic probe 15. The low frequencyrequirements of the present invention is a further advantage in that thelow frequency requirement leads to less damage to healthy tissue. Thoseskilled in the art understand it is possible to adjust the dimensions ofthe ultrasonic probe 15, including diameter, length and distance to theultrasonic energy source 99, in order to affect the number and spacingof the transverse nodes 40 and transverse anti-nodes 42 along a portionof the longitudinal axis of the ultrasonic probe 15.

[0061] The present invention allows the use of ultrasonic energy to beapplied to occlusions 16 selectively, because the ultrasonic probe 15conducts energy across a frequency range from about 20 kHz through about80 kHz. The amount of ultrasonic energy to be applied to a particulartreatment site is a function of the amplitude and frequency of vibrationof the ultrasonic probe 15. In general, the amplitude or throw rate ofthe energy is in the range of about 25 microns to about 250 microns, andthe frequency in the range of about 20 kHz to about 80 kHz. In apreferred embodiment of the present invention, the frequency ofultrasonic energy is from about 20 kHz to about 35 kHz. Frequencies inthis range are specifically destructive of occlusions 16 including, butnot limited to, hydrated (water-laden) tissues such as endothelialtissues, while substantially ineffective toward high-collagen connectivetissue, or other fibrous tissues including, but not limited to, vasculartissues, epidermal, or muscle tissues.

[0062] The amount of cavitation energy to be applied to a particularsite requiring treatment is a function of the amplitude and frequency ofvibration of the ultrasonic probe 15, the longitudinal length of theultrasonic probe 15, the geometry at the distal end 24 of the ultrasonicprobe 15, the proximity of the ultrasonic probe 15 to the occlusion 16,and the degree to which the length of the ultrasonic probe 15 is exposedto the occlusion 16. Reducing the amount of energy from the ultrasonicsource can reduce the amount of damage to healthy tissue.

[0063] In a preferred embodiment of the present invention, thetransducer transmits ultrasonic energy from the ultrasonic energy source99 to the longitudinal axis of the ultrasonic probe 15 to oscillate theultrasonic probe 15 in a direction transverse to its longitudinal axis.In a preferred embodiment of the present invention, the transducer is apiezoelectric transducer that is coupled to the ultrasonic probe 15 toenable transfer of ultrasonic excitation energy and cause the ultrasonicprobe 15 to oscillate in the transverse direction relative to thelongitudinal axis. In an alternative embodiment of the presentinvention, a magneto-strictive transducer may be used for transmissionof the ultrasonic energy.

[0064] In a preferred embodiment of the present invention, thepharmacological agent is tissue plasminogen activator (tPA). tPA is athrombolytic agent that breaks up or dissolves blood clots. tPA has beenapproved by the Food and Drug Administration since 1996 for thetreatment of stroke and heart attack. tPA acts in a two stage process todissolve fibrin clots that may be found in a vasculature of the body.Fibrin can be split up by plasmin, where a multitude of plasminmolecules can diffuse through aqueous channels in the fibrin clot to cutthe connector rods that comprise the fibrin. In order to form plasmin,tPA binds to a component of the clot called fibrin and activatesplasminogen to form plasmin. Plasmin degrades components of the clot andother proteins that promote the blood clotting.

[0065] There are several other pharmacological agents that treatocclusions 16 and can be used for the present invention. Antiplateletagents prevent a formation of blood platelets, a collection of smallblood cells having a disc shape. Blood platelets are an importantcomponent to the blood clotting process with the blood plateletscollecting to form a blood clot. Aspirin is the most common antiplateletagent that is used to prevent clots. Aspirin is also known as anonsteroidal anti-inflammatory agent that stops blood platelets fromsticking together and forming a blood clot. Glycoprotein inhibitors arepotent blood thinning agents that block platelets and include abciximab,Eptifibatide, tirofiban and lamifiban. Thienopyrindines are oralplatelet inhibitors and include clopidogrel and ticlopidine.Anticoagulants, including heparin and warfarin are also used to helpthin blood. Lysing agents work to break up or disintegrate the occlusion16. Dipyridamole is similar to aspirin in that it inhibits plateletadhesion, and thus tends to prevent the vascular thrombosis of heartattacks and strokes. Hirudin is an anticoagulant peptide whoseanticoagulant activity comes from the chemical ability to inhibitthrombus formation. Urokinase and streptokinase, thrombolytic agentssimilar to tPA, work by activating the body's own fibrinolytic system byactivating the production of plasmin from plasminogen. Those skilled inthe art will recognize there are other pharmacological agents known inthe art that can be used to treat occlusions that are within the spiritand scope of the present invention.

[0066] The ultrasonic probe 15 is designed to have the cross sectionwith a small profile, which also allows the ultrasonic probe 15 to flexalong its length, thereby allowing the ultrasonic probe 15 to be used ina minimally invasive manner. A significant feature of the presentinvention resulting from the transversely generated energy is theretrograde movement of biological material, e.g., away from the probetip 9 and along the longitudinal axis of the ultrasonic probe 15.

[0067] In a preferred embodiment of the present invention, theultrasonic probe 15 has a small diameter. In a preferred embodiment ofthe present invention, the diameter of the ultrasonic probe 15 graduallydecreases from the proximal end 31 to the distal end 24. In anembodiment of the present invention, the diameter of the distal end 24of the ultrasonic probe 15 is about 0.004 inches. In another embodimentof the present invention, the diameter of the distal end 24 of theultrasonic probe 15 is about 0.015 inches. In other embodiments of thepresent invention, the diameter of the distal end 24 of the ultrasonicprobe 15 varies between about 0.003 inches and about 0.025 inches. Thoseskilled in the art will recognize an ultrasonic probe 15 can have adiameter at the distal end 24 smaller than about 0.003 inches, largerthan about 0.025 inches, and between about 0.003 inches and about 0.025inches and be within the spirit and scope of the present invention.

[0068] In an embodiment of the present invention, the diameter of theproximal end 31 of the ultrasonic probe 15 is about 0.012 inches. Inanother embodiment of the present invention, the diameter of theproximal end 31 of the ultrasonic probe 15 is about 0.025 inches. Inother embodiments of the present invention, the diameter of the proximalend 31 of the ultrasonic probe 15 varies between about 0.003 inches andabout 0.025 inches. Those skilled in the art will recognize theultrasonic probe 15 can have a diameter at the proximal end 31 smallerthan about 0.003 inches, larger than about 0.025 inches, and betweenabout 0.003 inches and about 0.025 inches and be within the spirit andscope of the present invention.

[0069] In an embodiment of the present invention, the diameter of theultrasonic probe 15 is approximately uniform from the proximal end 31 tothe distal end 24 of the ultrasonic probe 15. In another embodiment ofthe present invention, the diameter of the ultrasonic probe 15 graduallydecreases from the proximal end 31 to the distal end 24. In anembodiment of the present invention, the ultrasonic probe 15 mayresemble a wire. In an embodiment of the present invention, the gradualchange of the diameter from the proximal end 31 to the distal end 24occurs over the at least one diameter transitions 82 with each diametertransition 82 having an approximately equal length. In anotherembodiment of the present invention, the gradual change of the diameterfrom the proximal end 31 to the distal end 24 occurs over a plurality ofdiameter transitions 82 with each diameter transition 82 having avarying length. The diameter transition 82 refers to a section where thediameter varies from a first diameter to a second diameter.

[0070] The length of the ultrasonic probe 15 of the present invention ischosen so as to be resonant in a transverse mode. In an embodiment ofthe present invention, the ultrasonic probe 15 is between about 30centimeters and about 300 centimeters in length. In an embodiment of thepresent invention, the ultrasonic probe is a wire. Those skilled in theart will recognize an ultrasonic probe can have a length shorter thanabout 30 centimeters and a length longer than about 300 centimeters andbe within the spirit and scope of the present invention.

[0071] The ultrasonic probe 15 is inserted into a vasculature 44 of thebody and may be disposed of after use. In a preferred embodiment of thepresent invention, the ultrasonic probe 15 is for a single use and on asingle patient. In a preferred embodiment of the present invention, theultrasonic probe 15 is disposable. In another embodiment of the presentinvention, the ultrasonic probe 15 can be used multiple times.

[0072]FIG. 5 shows a fragmentary side view of the ultrasonic probe 15within the catheter 36. The ultrasonic probe 15 comprises the distal end24 and the probe tip 9. The catheter comprises the plurality offenestrations 13 at the distal end 34 of the catheter 36. In theembodiment of the present invention shown in FIG. 5, the distal end 24with the probe tip 9 of the ultrasonic probe 15 is within the catheter36. There is an open area 19 between the ultrasonic probe 15 and thecatheter 36. The pharmacological agent is advanced between the open area19 and moves through the plurality of fenestrations 13.

[0073]FIG. 6 shows a fragmentary side view of the ultrasonic probe 15within the catheter 36 wherein the section of the longitudinal axis ofthe ultrasonic probe 15 extends past a distal end 34 of the catheter.

[0074] The present invention also provides a method of treating anocclusion 16 through a combination of the ultrasonic probe 15 and thepharmacological agent. The ultrasonic probe 15 is inserted into thevasculature 44 of the body and the catheter 36 is delivered over alength of the longitudinal axis of the ultrasonic probe 15 as shown inFIG. 5. In another embodiment of the present invention, the catheter 36is inserted into the vasculature 44 of the body and the ultrasonic probe15 is moved within the catheter 36. As the catheter 36 is inserted intothe vasculature 44, the placement wings 95 engage the patient's skin tosecure the catheter 36. The connecting tube 79 is opened by the one ormore valves 97 and a pharmacological agent is released through thecatheter 36 into the open area 19 between the ultrasonic probe 15 andthe catheter 36. The pharmacological agent engages the occlusion 16. Asection of the longitudinal axis of the ultrasonic probe 15 is advancedpast a distal end 34 of the catheter as shown in FIG. 6. The section ofthe longitudinal axis of the ultrasonic probe 15 is exposed to theocclusion 16 and the ultrasonic source 99 is activated. In oneembodiment of the present invention, the section of the longitudinalaxis of the ultrasonic probe 15 is exposed by pushing the section of thelongitudinal axis of the ultrasonic probe 15 past the distal end 34 ofthe catheter 36. In another embodiment of the present invention, thesection of the longitudinal axis of the ultrasonic probe 15 is exposedby pulling back on the catheter 36. The pharmacological agent enhancesan occlusion treating effect of the ultrasonic probe 15 by working incombination with the ultrasonic probe 15 at the site of the occlusion 16and downstream of the site of the occlusion 16. The combination of theultrasonic energy from the ultrasonic probe 15 and the pharmacologicalagent breaks up the occlusion 16 into the particulate that is carried bythe blood stream downstream of the site of the occlusion 16. Sizes ofthe particulate vary from a smallest size that can be easily absorbedand discharged through the body in conventional ways to a size that mayhave a risk of a subsequent occlusion 16 formation downstream. Thecombination of the ultrasonic energy from the ultrasonic probe 15 andthe pharmacological agent further breaks up the particulate into anaggregate downstream of the particulate. The size of the aggregate issuch that the aggregate is easily discharged from the body inconventional ways or is simply dissolved into the blood stream.

[0075] The use of the pharmacological agent in conjunction with theultrasonic probe 15 is a reliable method of effecting removing theocclusion 16 that is also cost effective. In addition to suffering fromcomplications and not being effective when used alone, the use ofpharmacological agents alone requires a large quantity of thepharmacological agent to treat the occlusion 16. The present inventionrequires a lower quantity of the pharmacological agent due to thecombinational effects of the pharmacological agent with the ultrasonicprobe 15. The lower amount of the pharmacological agent translates intoa more cost effective solution that also includes the added benefit ofmore effective occlusion 16 removal.

[0076] The present invention also provides a method of removing anocclusion 16 by moving the ultrasonic probe 15 through the vasculature44 to the site of the occlusion 16 and releasing a pharmacological agentin the vasculature 44. An ultrasonic energy source is activated and thelongitudinal axis of the ultrasonic probe 15 is vibrated in thetransverse direction. The pharmacological agent enhances an occlusiondestroying effect of the ultrasonic probe 15. The pharmacological agentengages the occlusion 16 and moves downstream of the site of theocclusion 16 with the particulate. While moving downstream, thepharmacological agent continues to break up the particulate to theaggregate.

[0077] The present invention provides an apparatus and a method for morecompletely removing an occlusion 16 by using a pharmacological agent inconjunction with an ultrasonic probe 15 to enhance an occlusion treatingeffect of the ultrasonic probe 15. The pharmacological agent isdelivered through a plurality of fenestrations 13 of the catheter 36 andtreats the occlusion 16 at the site of the occlusion 16 and continues totravel downstream of the site of the occlusion 16. The combination ofthe pharmacological agent and the transverse vibrations of theultrasonic probe 15 breaks up the occlusion 16 into a particulatedownstream of the site of the occlusion 16 and continues to treat theparticulate and breaks up the particulate into an aggregate to a sizethat is easily removed from the body in conventional ways. The presentinvention provides an apparatus and a method for more completelyremoving an occlusion that is safe, simple, efficient, effective,user-friendly, reliable and cost effective.

[0078] All patents, patent applications, and published references citedherein are hereby incorporated herein by reference in their entirety.While this invention has been particularly shown and described withreferences to preferred embodiments thereof, it will be understood bythose skilled in the art that various changes in form and details may bemade therein without departing from the scope of the inventionencompassed by the appended claims.

What is claimed is:
 1. An ultrasonic medical device comprising: acatheter having a proximal end, a distal end and a plurality offenestrations along a longitudinal axis of the catheter; and anultrasonic probe inserted into the catheter, the ultrasonic probe havinga proximal end, a distal end and a longitudinal axis therebetween,wherein the catheter delivers a pharmacological agent to dissolve anocclusion and the ultrasonic probe vibrates in a transverse mode toablate the occlusion along a portion of the longitudinal axis of theultrasonic probe and a probe tip.
 2. The ultrasonic medical device ofclaim 1 wherein the plurality of fenestrations are spacedcircumferentially along the catheter.
 3. The ultrasonic medical deviceof claim 1 wherein the plurality of fenestrations are located at thedistal end of the catheter.
 4. The ultrasonic medical device of claim 1wherein the occlusion comprises a biological material.
 5. The ultrasonicmedical device of claim 1 wherein the pharmacological agent softens theocclusion.
 6. The ultrasonic medical device of claim 1 wherein thepharmacological agent moves in a radial direction through the pluralityof fenestrations.
 7. The ultrasonic medical device of claim 1 whereinthe pharmacological agent is a tissue plasminogen activator.
 8. Theultrasonic medical device of claim 1 wherein the pharmacological agentis selected from a group consisting of thrombolytic agents, antiplateletdrugs, lysing agents, anticoagulants and similar agents that treat theocclusion.
 9. The ultrasonic medical device of claim 1 wherein thepharmacological agent is selected from a group consisting of aspirin,dipyridamole, glycoprotein inhibitors, thienopyrindines, clopidogrel,hirudin, urokinase, streptokinase, heparin, warfarin and similar agentsthat treat the occlusion.
 10. The ultrasonic medical device of claim 1wherein a transverse ultrasonic vibration of the ultrasonic probeproduces a plurality of transverse nodes and a plurality of transverseanti-nodes along a portion of the longitudinal axis of the ultrasonicprobe.
 11. The ultrasonic medical device of claim 1 wherein theultrasonic probe ablates the occlusion adjacent to a plurality oftransverse anti-nodes along the portion of the longitudinal axis of theultrasonic probe.
 12. The ultrasonic medical device of claim 1 whereinthe ultrasonic probe is disposable.
 13. The ultrasonic medical device ofclaim 1 wherein the ultrasonic probe is for a single use on a singlepatient.
 14. An ultrasonic medical device for destroying a biologicalmaterial comprising: a catheter having a proximal end, a distal end anda plurality of fenestrations along a longitudinal axis of the catheter;an ultrasonic probe inserted into the catheter; and a pharmacologicalagent delivered through the catheter to enhance a biological materialdestroying effect of the ultrasonic probe vibrating in a transverse modealong a portion of a longitudinal axis of the ultrasonic probe and aprobe tip.
 15. The ultrasonic medical device of claim 14 wherein thepharmacological agent moves through an open area between the ultrasonicprobe and the catheter.
 16. The ultrasonic medical device of claim 14wherein the pharmacological agent moves in a radial direction throughthe plurality of fenestrations along the catheter.
 17. The ultrasonicmedical device of claim 14 wherein the plurality of fenestrations arespaced circumferentially along the catheter.
 18. The ultrasonic medicaldevice of claim 14 wherein the pharmacological agent is a tissueplasminogen activator.
 19. The ultrasonic medical device of claim 14wherein the pharmacological agent is selected from a group consisting ofthrombolytic agents, antiplatelet drugs, lysing agents, anticoagulantsand similar agents that treat the biological material.
 20. Theultrasonic medical device of claim 14 wherein the pharmacological agentis selected from a group consisting of aspirin, dipyridamole,glycoprotein inhibitors, thienopyrindines, clopidogrel, hirudin,urokinase, streptokinase, heparin, warfarin and similar agents thattreat the biological material.
 21. The ultrasonic medical device ofclaim 14 wherein a transverse ultrasonic vibration of the ultrasonicprobe produces a plurality of transverse nodes and a plurality oftransverse anti-nodes along a portion of the longitudinal axis of theultrasonic probe.
 22. The ultrasonic medical device of claim 14 whereinthe ultrasonic probe destroys the biological material adjacent to aplurality of transverse anti-nodes along the portion of the longitudinalaxis of the ultrasonic probe.
 23. The ultrasonic medical device of claim14 wherein more than one of the plurality of transverse anti-nodes arein communication with the biological material.
 24. The ultrasonicmedical device of claim 14 wherein the pharmacological agent dissolvesthe biological material.
 25. A method of ablating a biological materialcomprising: delivering a catheter into a vasculature; inserting anultrasonic probe into the catheter, the ultrasonic probe having aproximal end, a distal end and a longitudinal axis therebetween;releasing a pharmacological agent through the catheter, thepharmacological agent moving through a plurality of fenestrationslocated along the catheter to dissolve the biological material;extending a section of the longitudinal axis of the ultrasonic probebeyond a distal end of the catheter; and activating an ultrasonic energysource coupled to the ultrasonic probe to generate an ultrasonic energythat produces a transverse ultrasonic vibration of the ultrasonic probe;and ablating the biological material adjacent to the section of thelongitudinal axis of the ultrasonic probe and a probe tip.
 26. Themethod of claim 25 wherein the pharmacological agent and the ultrasonicprobe work in combination to ablate the biological material.
 27. Themethod of claim 25 further comprising pushing the section of thelongitudinal axis of the ultrasonic probe beyond the distal end of thecatheter.
 28. The method of claim 25 further comprising pulling back thecatheter to extend the section of the longitudinal axis of theultrasonic probe beyond the distal end of the catheter.
 29. The methodof claim 25 further comprising engaging the pharmacological agent to thebiological material and moving the pharmacological agent downstream fromthe biological material.
 30. The method of claim 25 wherein thepharmacological agent is localized at the biological material.
 31. Themethod of claim 25 further comprising breaking up the biologicalmaterial into a particulate with a combination of the ultrasonic energyfrom the ultrasonic probe and the pharmacological agent.
 32. The methodof claim 31 further comprising breaking up the particulate into anaggregate with a combination of the ultrasonic energy and thepharmacological agent.
 33. The method of claim 25 further comprisingproducing a plurality of transverse nodes and a plurality of transverseanti-nodes along the section of the longitudinal axis of the ultrasonicprobe.
 34. The method of claim 25 further comprising ablating thebiological material adjacent to a plurality of transverse anti-nodesalong the section of the longitudinal axis of the ultrasonic probe. 35.The method of claim 25 wherein the pharmacological agent is a tissueplasminogen activator.
 36. The method of claim 25 wherein thepharmacological agent is selected from a group consisting ofthrombolytic agents, antiplatelet drugs, lysing agents, anticoagulantsand similar agents that treat the occlusion.
 37. The method of claim 25wherein the pharmacological agent is selected from a group consisting ofaspirin, dipyridamole, glycoprotein inhibitors, thienopyrindines,clopidogrel, hirudin, urokinase, streptokinase, heparin, warfarin andsimilar agents that treat the occlusion.
 38. A method of destroying abiological material comprising: delivering a catheter into avasculature; inserting an ultrasonic probe into the catheter, theultrasonic probe having a proximal end, a distal end and a longitudinalaxis therebetween; releasing a pharmacological agent through a pluralityof fenestrations along the catheter to dissolve the biological material;exposing a section of the longitudinal axis of the ultrasonic probe; andactivating an ultrasonic energy source coupled to the ultrasonic probeto generate an ultrasonic energy; and vibrating in a transverse mode atleast the section of the longitudinal axis of the ultrasonic probe and aprobe tip to destroy the biological material.
 39. The method of claim 38further comprising pushing the section of the longitudinal axis of theultrasonic probe beyond a distal end of the catheter.
 40. The method ofclaim 38 further comprising pulling back on the catheter to expose thesection of the longitudinal axis of the ultrasonic probe beyond a distalend of the catheter.
 41. The method of claim 38 further comprisingproducing a plurality of transverse nodes and a plurality of transverseanti-nodes along the section of the longitudinal axis of the ultrasonicprobe.
 42. The method of claim 38 further comprising ablating thebiological material adjacent to a plurality of transverse anti-nodesalong the section of the longitudinal axis of the ultrasonic probe. 43.The method of claim 38 further comprising breaking up the particulateinto an aggregate with a combination of the ultrasonic energy and thepharmacological agent.